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[Prognostic factors for visual outcome after intravitreal drug therapy for chronic diabetic macular oedema].
Guthoff, R, Schrader, W, Hennemann, K, Meigen, T, Göbel, W
Klinische Monatsblatter fur Augenheilkunde. 2011;(5):468-72
Abstract
BACKGROUND In recent years, intravitreal bevacizumab and triamcinolone acetonide (TA) have been widely used to treat diabetic macular oedema (DMO). However, the indication criteria are not clear. The purpose of this study was to evaluate factors which are decisive for long-term visual outcome after intravitreal drug treatment for eyes with DMO. MATERIALS AND METHODS Fifty eyes (37 patients) treated with intravitreal bevacizumab, TA, or sequentially with both for DMO with a minimum follow-up period of 6 months were analysed retrospectively. The eyes with an increase of best-corrected visual acuity (BCVA) at the last visit were classified as gainers, and eyes with stable or decreased BCVA as non-gainers. Clinical and imaging findings were evaluated. RESULTS BCVA significantly increased in 22 eyes and decreased in 28 eyes after a mean follow-up period of 14.6 ± 6 months after initial intravitreal intervention. Unfavourable for the long-term visual outcome was the presence of cystoid macular oedema (CMO, p < 0.001), whereas an early response at 5 weeks into therapy indicated a positive outcome (p = 0.016). The initial central macular thickness measured by OCT, the type of agent used in monotherapy, age and gender were without influence on long-term visual acuity. CONCLUSIONS An initial CMO is unfavourable for the prognosis of long-term visual outcome of DMO. Hence, benefit from intravitreal treatment with bevacizumab and/or TA is more likely in the early stages of chronic DMO before CMO has evolved. In eyes without CMO even a low number of injections is beneficial. An early response following intravitreal bevacizumab or TA is a predictor of long-term benefit.
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Bevacizumab (Avastin) as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy: a prospective case series.
Abdelhakim, MA, Macky, TA, Mansour, KA, Mortada, HA
Ophthalmic research. 2011;(1):23-30
Abstract
PURPOSE To evaluate the role of preoperative intravitreal bevacizumab as an adjunct to vitrectomy in diabetic eye disease. METHODS Twenty eyes of 18 patients were recruited and underwent a single intravitreal injection of bevacizumab 1.25 mg 1 week prior to vitrectomy. Fundus fluorescein angiography (FFA) was done before and 1 week after injections. Best corrected visual acuity (BCVA) and ophthalmic evaluation were done before, 1 week after injections, 1 day, 1 week and monthly for 3 months after vitrectomy. RESULTS The mean age was 47.7 ± 10.39 years. The male:female ratio was 2:3. Mean preinjection BCVA (logMAR) was 1.460 ± 0.439. FFA showed a dramatic reduction in dye leakage 1 week after injection. Intraoperative bleedings were minimal in most cases (85%, n = 17). Postoperatively, 16 patients had no bleeding (80%), 4 had minimal bleeding (20%), and 1 had recurrent fibrovascular proliferation (5%). The mean BCVA on day 1, week 1, months 2 and 3 after surgery were 1.645 ± 0.422, 1.300 ± 0.413, 1.065 ± 0.538 and 1.065 ± 0.538 logMAR, respectively (p = 0.078, 0.123, 0.002 and 0.002, respectively). CONCLUSION Bevacizumab administered prior to vitrectomy was well tolerated and was particularly useful during surgery.
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Prospective clinical trial: enteral nutrition during maintenance infliximab in Crohn's disease.
Yamamoto, T, Nakahigashi, M, Umegae, S, Matsumoto, K
Journal of gastroenterology. 2010;(1):24-9
Abstract
PURPOSE Hitherto, the efficacy of enteral nutrition (EN) on clinical outcomes during biological maintenance therapy in Crohn's disease (CD) has not been investigated. This prospective study was to assess the efficacy of EN on the maintenance rate of clinical remission in patients with quiescent CD receiving infliximab as maintenance therapy. METHODS Fifty-six patients who achieved clinical remission with infliximab induction therapy received infliximab as maintenance therapy (5 mg/kg, every 8 weeks). Thirty-two of the 56 patients received concomitant EN: elemental diet infusion during night-time and a low fat diet during daytime (EN group), while the remaining 24 patients received neither nutritional therapy nor food restriction (non-EN group). All patients were followed for 56 weeks; CD activity index (CDAI) was assessed and CDAI < 150 was defined as clinical remission. RESULTS During the 56-week observation, the mean CDAI was not significantly different between the 2 groups. Seven patients in the EN group ceased EN therapy because they maintained complete remission. On an intention-to-treat basis, 25 patients in the EN group (78%) and 16 patients in the non-EN group (67%) remained in clinical remission during the 56-week observation (P = 0.51). CONCLUSIONS The outcomes of this prospective study showed that concomitant EN during infliximab maintenance therapy does not significantly increase the maintenance rate of clinical remission in patients with CD.
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PNL2 melanocytic marker in immunohistochemical evaluation of primary mucosal melanoma of the head and neck.
Morris, LG, Wen, YH, Nonaka, D, DeLacure, MD, Kutler, DI, Huan, Y, Wang, BY
Head & neck. 2008;(6):771-5
Abstract
BACKGROUND Histologic diagnosis of mucosal melanoma of the head and neck is difficult, requiring immunohistochemical stains which are less reliable than in cutaneous lesions. PNL-2 is a novel marker that has not been examined in mucosal melanoma. METHODS Nine formalin-fixed tissue sections of mucosal melanoma were stained with PNL-2, human melanoma black (HMB)-45, Melan-A, S-100, and microphthalmia transcription factor (MITF). RESULTS Disease in all 9 patients arose from the sinonasal mucosa. Rates of diffuse positive staining with the 4 stains were PNL-2 (77.8%), HMB-45 (77.8%), Melan-A (50%), S-100 (87.5%), and MITF (40%). In 3 patients, PNL2 staining was superior to Melan-A or MITF. CONCLUSION We report the first characterization of PNL-2 staining in head and neck mucosal melanoma. PNL-2 demonstrates high sensitivity for mucosal melanoma, likely superior to Melan-A and MITF, and comparable to HMB-45, with specificity superior to S-100. We advocate inclusion of PNL2 as an important adjunctive marker in the evaluation of these lesions.
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[Bevacizumab for the treatment of macular edema secondary to retinal vein occlusion].
Schaal, KB, Höh, AE, Scheuerle, A, Schütt, F, Dithmar, S
Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft. 2007;(4):285-9
Abstract
BACKGROUND Retinal vein occlusion often leads to macular edema as a result of an elevated level of intravitreal VEGF. We report on the anatomic and functional results after intravitreal bevacizumab injections in patients with retinal vein occlusion. METHODS In a prospective study, 18 patients with central, and 22 patients with branch retinal vein occlusion, all of whom had persistent macular edema (>300 microm) received 2.5 mg intravitreal bevacizumab. ETDRS visual acuity, ophthalmic examination and stratus OCT were performed at baseline, 1 week after injection and then monthly. Further injections were given every 6 weeks in patients with persistent or recurring macular edema. RESULTS The findings did not deteriorate in any of the 40 patients. The injections (mean of 2.6+/-1.4 injections/patient) were very well tolerated in all cases during a mean follow-up of 23+/-13 weeks. On the last visit, 73.3% of patients with central retinal vein occlusion and 76.5% of those with branch retinal vein occlusion were found to have significantly improved visual acuity (by at least 3 lines). Mean central retinal thickness had decreased from 921+/-264 to 239+/-66.2 microm in patients with central retinal vein occlusion, and from 678+/-221 to 236+/-78 microm in patients with branch retinal vein occlusion. CONCLUSIONS Neither intraocular nor systemic side-effects were observed in this study after repeated intravitreal injections of 2.5 mg bevacizumab. Current results suggest that intravitreal anti-VEGF therapy is a promising option in macular edema secondary to retinal vein occlusion.
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Effects of repeated infliximab therapy on serum lipid profile in patients with refractory rheumatoid arthritis.
Allanore, Y, Kahan, A, Sellam, J, Ekindjian, OG, Borderie, D
Clinica chimica acta; international journal of clinical chemistry. 2006;(1-2):143-8
Abstract
BACKGROUND Patients with rheumatoid arthritis (RA) frequently display an atherogenic lipid profile which has been linked with inflammation. Tumor necrosis factor-alpha (TNF-alpha), a pivotal pro-inflammatory cytokine in RA may be involved in the development of the disturbed lipid metabolism. We investigated whether infliximab, an anti-TNF-alpha therapy, may modify the lipid profile. METHODS 56 consecutive RA patients were treated with infliximab (3 mg/kg at weeks 0, 2, 6, 14, 22, 30). Lipid profile and CRP were assayed at baseline and before infusion at weeks 6 and 30. Baseline values were compared with those in 56 healthy volunteers. RESULTS At baseline, the concentrations of HDL-cholesterol were lower in RA patients than in the controls (1.3+/-0.4 vs. 1.5+/-0.2 mmol/L; p<0.01). The triglyceride concentrations (1.6+/-0.8 vs. 1.3+/-0.4 mmol/L, p<0.01), the ratio of total cholesterol/HDL-cholesterol (4.3+/-1.6 vs. 3.2+/-0.5, p<0.001) and LDL-cholesterol/HDL-cholesterol (2.6+/-1.2 vs. 1.7+/-0.5, p<0.001) were significantly higher in RA patients than in controls. After 6 weeks of infliximab therapy, the mean total cholesterol concentration increased by 25% (p<0.001), LDL-cholesterol by 24% (p<0.001) and HDL-cholesterol by 30% (p<0.001). The decrease in CRP levels to 30 week inversely correlated with the increase in HDL-cholesterol (r=-0.47, p=0.005). CONCLUSIONS Infliximab administration is associated with important increases in cholesterol levels in all its forms but as no significant beneficial effect on the atherogenic ratio.
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The renal-sparing efficacy of basiliximab in adult living donor liver transplantation.
Lin, CC, Chuang, FR, Lee, CH, Wang, CC, Chen, YS, Liu, YW, Jawan, B, Chen, CL
Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. 2005;(10):1258-64
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Abstract
The purpose of this study is to find out whether basiliximab administration will improve postoperative renal function by delaying the start of tacrolimus and decreasing of dosage requirement for tacrolimus in adult living donor liver transplantation (LDLT). Forty-five adult LDLT recipients were enrolled in the study. The induction group (n = 27) was given basiliximab 20 mg on days 0 and 4; tacrolimus administration was delayed until renal function improved. The control group (n = 18) did not receive basiliximab; tacrolimus was given on the first postoperative day. Trough levels of tacrolimus in the induction and control groups were aimed to be maintained at 5-10 ng/ml and 10-15 ng/ml during the first week after transplant, respectively. The median follow-up was 22 months (range 10-34 months). The preoperative conditions were poorer in the induction group (Child C, 56% vs. 33%, P = 0.01; UNOS 2a, 15% vs. 0%, P = 0.02). The intraoperative blood loss was also higher in the induction group than in the control group (median 2,180 ml vs. 495 ml, P < 0.01). The median delay in tacrolimus administration in the induction group was 36 hours (range 24-108 hours). Serum creatinine levels at second and third postoperative months were significantly lower in the induction group. The creatinine clearance rate in the induction group was higher at the third month posttransplant (median 72 vs. 57 ml/minute, P = 0.04). The incidence of renal insufficiency was significantly lower in the induction group at the third month posttransplant (26% vs. 67%, P < 0.01). Blood cholesterol level at the sixth month posttransplant was lower in the induction group (median 152 vs. 196 mg/dl P = 0.03). The incidences of acute cellular rejection, bacteremia, and cytomegalovirus (CMV) infection were similar in both groups. In conclusion, for pretransplant critical patients with more intraoperative blood loss, basiliximab induction could prevent early renal dysfunction by delaying the start of tacrolimus and reducing the dose requirement of tacrolimus without increasing graft rejection and infection. Furthermore, it also improved renal function as well as lowered cholesterol levels within 6 months after transplantation.
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Influence of anti-tumour necrosis factor therapy on cardiovascular risk factors in patients with active rheumatoid arthritis.
Popa, C, Netea, MG, Radstake, T, Van der Meer, JW, Stalenhoef, AF, van Riel, PL, Barerra, P
Annals of the rheumatic diseases. 2005;(2):303-5
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Abstract
BACKGROUND Tumour necrosis factor (TNF) is known to increase the concentrations of interleukin (IL) 6 and C reactive protein (CRP) and to induce proatherogenic changes in the lipid profile and may increase the cardiovascular risk of patients with rheumatoid arthritis (RA) and other inflammatory disorders. OBJECTIVE To assess whether anti-TNF therapy modifies the cardiovascular risk profile in patients with RA. METHODS The lipoprotein spectrum and the inflammation markers CRP and IL6 were investigated in 33 patients with RA treated with human anti-TNF monoclonal antibodies (D2E7, adalimumab, Humira) and 13 patients with RA given placebo, before and after 2 weeks' treatment. RESULTS In the anti-TNF treated group, the mean (SD) concentrations of HDL-cholesterol were significantly higher after 2 weeks' treatment (0.86 (0.30) mmol/l v 0.98 (0.33) mmol/l, p<0.01), whereas LDL and triglyceride levels were not significantly changed. Additionally, a significant decrease in CRP (86.1 (54.4) mg/l v 35.4 (35.0) mg/l, p<0.0001), and IL6 (88.3 (60.5) pg/ml v 42.3 (40.7) pg/ml, p<0.001) concentrations was seen in this group. No changes in lipid profile, IL6, or CRP levels were seen in the placebo group. CONCLUSIONS TNF neutralisation with monoclonal anti-TNF antibodies increased HDL-cholesterol levels and decreased CRP and IL6 levels after 2 weeks. Therefore this treatment may improve the cardiovascular risk profile of patients with RA.
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Effect of anti-IL-6 and anti-10 monoclonal antibodies on the suppression of the normal T lymphocyte mitogenic response by steady state sickle cell disease sera.
Taylor, S, Shacks, S, Qu, Z
Immunological investigations. 2001;(3):209-19
Abstract
Previously published work has shown that sera from healthy sickle cell disease (SCD) patients inhibits normal lymphocyte mitogenic response to phytohemagglutinin (PHA) in vitro. The current study is to attempt to ascertain what effect antibody to type 2 cytokines, interleukin (IL)-6 and 10, have on the suppression of lymphocyte PHA response by SCD sera. Peripheral blood mononuclear cells (PBMC), separated by density gradient were obtained from 2 healthy normal donors. Sera from 50 healthy SCD patients, 50 normal healthy controls and pooled normal O, Rh+ (O+) sera were utilized in standard in vitro PHA stimulation of PBMC cultures. Mitogenic responses were expressed as mean counts per minute (cpm) of triplicate cultures. Fifty triplicate cultures of PHA stimulated normal PBMC were done with 10% normal pooled O+, normal control and SCD steady state sera only. In addition 50 cultures were done with SCD sera containing 1 microg/ml of anti-IL-6 monoclonal antibody, as well as 28 SCD serum cultures containing 1 microg/ml of anti-IL-10 monoclonal antibody. The final 11 SCD serum culture experiments contained a combination of both anti-IL-6 and anti-IL-10 antibody, each at the concentration of 1 microg/ml. Results revealed > 15% suppression of mitogenic response in the SCD sera supplemented cultures as compared to control sera in 47/50 (94%) and in 40/50 (80%) of normal pooled O+, as calculated by mean cpm. The degree of suppression ranged from 17% to 98% in individual experiments. The addition of anti IL-6 antibody alone significantly improved mean cpm (> 20%) in 19/50 (38%) of SCD serum responses compared to O+ sera and 23/50 (46%) of control sera. Complete correction occurred in 9/50 (18%) of all SCD serum suppressions as compared to O+ sera and 6/50 (12%) when compared to control sera. Similarly, anti-IL-10 antibody decreased suppression of the mean cpm of SCD serum cultures in 18/28 (64%) and completely corrected 3/18 (11%). The combined antibody data revealed >20% increase in mean cpm in 10/11(91%) experiments. Inhibitors of mitogenic response were present in a significant percentage of the SCD sera utilized in the present study. The significant corrective effects of both monoclonal antibodies would seem to support the original hypothesis that high circulating levels of type 2 cytokines may represent the cell-mediated dependent inhibitory factors expressed in the sera of many healthy SCD patients.
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Effect of abciximab on cardiac enzyme elevation after transluminal extraction atherectomy (TEC) in high-risk saphenous vein graft lesions: comparison with a historical control group.
Khan, MA, Liu, MW, Chio, FL, Yates, VB, Chapman, GD, Misra, VK, Sweeney, A, Dean, LS
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2001;(1):40-4
Abstract
Saphenous vein graft (SVG) intervention has been associated with an increased incidence of distal embolization. Long lesions and lesions associated with thrombus are particularly at increased risk. This study was performed to determine whether abciximab may decrease this risk in high risk SVG angioplasty. From June 1994 to June 1998, 84 patients with at least one high risk factor, i.e., lesion length >20 mm or angiographic evidence of thrombus, underwent Transluminal extraction atherectomy (TEC) procedure followed by balloon dilatation or stenting. Of these 84 patients, 37 who had procedure after September 1995 underwent TEC with abciximab (Abciximab Group) and 47 who had their procedure before that date had TEC without abciximab thereby serving as historic control (Non-Abciximab Group). All patients had normal pre-procedure CK and CK-MB. Total creatine kinase (CK) and CK-MB were measured every 8 hr post-procedure for 24 hr. Baseline demographics, angiographic characteristics, incidence of LV dysfunction and triple vessel disease were similar between the two groups. Graft age was similar between two groups (122 +/- 70 vs. 117 +/- 54 months). Graft diameter, pre and post-procedure percent stenoses were not different between the two groups. Stents were used in 65% in the Abciximab group and 45% in Non-Abciximab group (P = 0. 14). There was no in-hospital repeat PTCA, urgent bypass surgery, or cardiac death. There was no difference between the two groups in regards to the incidence of any elevation of total CK (27% vs. 21. 3%) or CK-MB (54% vs. 51%). When used in conjunction with TEC in treating high risk vein graft lesions, abciximab did not reduce post procedure CK-MB elevation in this patient population.